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AzTrials

Gastric CancerPhase 2NCT05687617

Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.

A Phase 2 study testing Indocyanine green in people with Gastric Cancer and Gastric Adenocarcinoma, run by Laval University at 2 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Peritoneal disease at initial presentation for patients with gastric adenocarcinoma (GA) is frequent, with 15-31% of patients presenting with peritoneal metastases (PM) at surgical exploration. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Indocyanine green
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesCanada
Study dates
15 Dec 2022to 27 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of gastric adenocarcinoma.
  • Clinical stage cT2 or higher.
  • No evidence of metastatic disease on preoperative imaging.
  • Patient fit for surgery (ECOG 0 or 1).

Who cannot join

  • Indocyanine allergy.
  • Gastric cancer subtype other than gastric adenocarcinoma.
  • Unconfirmed diagnosis of gastric adenocarcinoma (unable to confirm diagnosis).
  • Clinical stage cT1b or lower.
  • Evidence of metastatic disease on preoperative imaging.
  • Patient unfit for surgery (ECOG 2 or more).

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • CIUSSS de l'Est-de-l'Île-de-Montréal

    Montreal, Quebec, H1T 2M4

  • CHU de Québec

    Québec, Quebec, G1R 2J6

Other trials in Canada

About this study

Official title: Diagnostic Value of Intraoperative Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases During Staging Laparoscopy for Gastric Adenocarcinoma: a Prospective, Multicentric Study.

Peritoneal disease at initial presentation for patients with gastric adenocarcinoma (GA) is frequent, with 15-31% of patients presenting with peritoneal metastases (PM) at surgical exploration. The prognosis of patients with PM is poor, overall survival (OS) ranging from 8 to 13 months, reinforcing the importance of optimal patient selection before surgical management of GA.

Indocyanine Green (ICG) fluorescence imaging for intraoperative detection of PM has been described in recent literature as a useful tool in patients undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal malignancies to increase the detection of PM during surgery. However, the role of ICG for patients with GA, and its role during diagnosic laparoscopy (DL), remain unknown.

Read the detailed description

This is a multicentric, prospective study . Patients will be referred to one of seven surgeons specialized in the surgical management of gastric cancer. Patients will undergo DL, with intravenous (IV) injection of 0.25 mg/kg of free ICG at the start of the surgery. DL will be first performed without fluorescence imaging in the standard fashion, with identification of potential PM. A first peritoneal cancer index (PCI) score will be calculated. Fluorescence imaging will then be performed, and correlation with previously identified lesions will be assessed and a second PCI score (with ICG) will be calculated. Biopsies will be performed to confirm the metastatic status of the lesions. Any suspicion for additional lesions visualized only under fluorescence imaging will be biopsied as well. Peritoneal fluid cytology will be performed at the beginning of the surgery.

Being tested
Indocyanine green
Keywords
Diagnostic laparoscopy, ICG
Medical subject headings
Stomach Neoplasms, Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine greenDrug

    Also called ICG

    0,25mg/kg IV at the start of the surgery,

Study groups in NCT05687617
Study groupRoleWhat they receive
Gastric cancer with ICGExperimentalPatient to receive IV ICG during diagnostic laparoscopy.
Receives: Drug: Indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with additional lesions detected with ICG.

    Patients with peritoneal metastases, in whom additional lesions are detected with ICG.

    Measured: 18 months

  2. Number of patients with peritoneal metastases detected only with ICG.

    Patients with peritoneal metastases, in whom lesions are detected only with ICG and diagnostic laparoscopy would be negative otherwise.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2023
  2. Study start15 Dec 2022
  3. Primary completion27 Mar 2024
  4. Study completion27 Mar 2024

Why it stopped: Recruitment lower than expected and negative results.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05687617
Sponsor's protocol ID
MP-20-2023-6524
Status last verified
Mar 2024
First submitted
8 Jan 2023
Last updated
2 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.

    PubMed 33433946

  • Ma J, Shen H, Kapesa L, Zeng S. Lauren classification and individualized chemotherapy in gastric cancer. Oncol Lett. 2016 May;11(5):2959-2964. doi: 10.3892/ol.2016.4337. Epub 2016 Mar 16.

    PubMed 27123046

  • Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008.

    PubMed 35130500

  • Al-Batran SE, Homann N, Pauligk C, Goetze TO, Meiler J, Kasper S, Kopp HG, Mayer F, Haag GM, Luley K, Lindig U, Schmiegel W, Pohl M, Stoehlmacher J, Folprecht G, Probst S, Prasnikar N, Fischbach W, Mahlberg R, Trojan J, Koenigsmann M, Martens UM, Thuss-Patience P, Egger M, Block A, Heinemann V, Illerhaus G, Moehler M, Schenk M, Kullmann F, Behringer DM, Heike M, Pink D, Teschendorf C, Lohr C, Bernhard H, Schuch G, Rethwisch V, von Weikersthal LF, Hartmann JT, Kneba M, Daum S, Schulmann K, Weniger J, Belle S, Gaiser T, Oduncu FS, Guntner M, Hozaeel W, Reichart A, Jager E, Kraus T, Monig S, Bechstein WO, Schuler M, Schmalenberg H, Hofheinz RD; FLOT4-AIO Investigators. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet. 2019 May 11;393(10184):1948-1957. doi: 10.1016/S0140-6736(18)32557-1. Epub 2019 Apr 11.

    PubMed 30982686

  • Granieri S, Bonomi A, Frassini S, Chierici AP, Bruno F, Paleino S, Kusamura S, Germini A, Facciorusso A, Deraco M, Cotsoglou C. Prognostic impact of cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) in gastric cancer patients: A meta-analysis of randomized controlled trials. Eur J Surg Oncol. 2021 Nov;47(11):2757-2767. doi: 10.1016/j.ejso.2021.05.016. Epub 2021 May 11.

    PubMed 34001385

  • Sarela AI, Lefkowitz R, Brennan MF, Karpeh MS. Selection of patients with gastric adenocarcinoma for laparoscopic staging. Am J Surg. 2006 Jan;191(1):134-8. doi: 10.1016/j.amjsurg.2005.10.015.

    PubMed 16399124

  • Al-Batran SE, Hartmann JT, Probst S, Schmalenberg H, Hollerbach S, Hofheinz R, Rethwisch V, Seipelt G, Homann N, Wilhelm G, Schuch G, Stoehlmacher J, Derigs HG, Hegewisch-Becker S, Grossmann J, Pauligk C, Atmaca A, Bokemeyer C, Knuth A, Jager E; Arbeitsgemeinschaft Internistische Onkologie. Phase III trial in metastatic gastroesophageal adenocarcinoma with fluorouracil, leucovorin plus either oxaliplatin or cisplatin: a study of the Arbeitsgemeinschaft Internistische Onkologie. J Clin Oncol. 2008 Mar 20;26(9):1435-42. doi: 10.1200/JCO.2007.13.9378.

    PubMed 18349393

  • Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Ruschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19.

    PubMed 20728210

  • Abdalla EK, Pisters PW. Staging and preoperative evaluation of upper gastrointestinal malignancies. Semin Oncol. 2004 Aug;31(4):513-29. doi: 10.1053/j.seminoncol.2004.04.014.

    PubMed 15297943

  • Mezhir JJ, Shah MA, Jacks LM, Brennan MF, Coit DG, Strong VE. Positive peritoneal cytology in patients with gastric cancer: natural history and outcome of 291 patients. Ann Surg Oncol. 2010 Dec;17(12):3173-80. doi: 10.1245/s10434-010-1183-0. Epub 2010 Jun 29.

    PubMed 20585870

  • De Andrade JP, Mezhir JJ. The critical role of peritoneal cytology in the staging of gastric cancer: an evidence-based review. J Surg Oncol. 2014 Sep;110(3):291-7. doi: 10.1002/jso.23632. Epub 2014 May 22.

    PubMed 24850538

  • Spolverato G, Ejaz A, Kim Y, Squires MH, Poultsides GA, Fields RC, Schmidt C, Weber SM, Votanopoulos K, Maithel SK, Pawlik TM. Rates and patterns of recurrence after curative intent resection for gastric cancer: a United States multi-institutional analysis. J Am Coll Surg. 2014 Oct;219(4):664-75. doi: 10.1016/j.jamcollsurg.2014.03.062. Epub 2014 Jun 26.

    PubMed 25154671

  • Bonnot PE, Lintis A, Mercier F, Benzerdjeb N, Passot G, Pocard M, Meunier B, Bereder JM, Abboud K, Marchal F, Quenet F, Goere D, Msika S, Arvieux C, Pirro N, Wernert R, Rat P, Gagniere J, Lefevre JH, Courvoisier T, Kianmanesh R, Vaudoyer D, Rivoire M, Meeus P, Villeneuve L, Piessen G, Glehen O; FREGAT and BIG-RENAPE Networks. Prognosis of poorly cohesive gastric cancer after complete cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (CYTO-CHIP study). Br J Surg. 2021 Oct 23;108(10):1225-1235. doi: 10.1093/bjs/znab200.

    PubMed 34498666

  • Brandl A, Yonemura Y, Glehen O, Sugarbaker P, Rau B. Long term survival in patients with peritoneal metastasised gastric cancer treated with cytoreductive surgery and HIPEC: A multi-institutional cohort from PSOGI. Eur J Surg Oncol. 2021 Jan;47(1):172-180. doi: 10.1016/j.ejso.2020.10.006. Epub 2020 Oct 14.

    PubMed 33071173

  • Baiocchi GL, Gheza F, Molfino S, Arru L, Vaira M, Giacopuzzi S. Indocyanine green fluorescence-guided intraoperative detection of peritoneal carcinomatosis: systematic review. BMC Surg. 2020 Jul 17;20(1):158. doi: 10.1186/s12893-020-00821-9.

    PubMed 32680492

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indocyanine green in people with Gastric Cancer and Gastric Adenocarcinoma, run by Laval University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment lower than expected and negative results.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with additional lesions detected with ICG. (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05687617, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.

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